AR050615A1 - PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION - Google Patents
PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATIONInfo
- Publication number
- AR050615A1 AR050615A1 ARP050103558A ARP050103558A AR050615A1 AR 050615 A1 AR050615 A1 AR 050615A1 AR P050103558 A ARP050103558 A AR P050103558A AR P050103558 A ARP050103558 A AR P050103558A AR 050615 A1 AR050615 A1 AR 050615A1
- Authority
- AR
- Argentina
- Prior art keywords
- granules
- therapeutic compound
- moisture sensitive
- mixture
- fusion
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 239000008187 granular material Substances 0.000 abstract 6
- 230000004927 fusion Effects 0.000 abstract 5
- 150000001875 compounds Chemical class 0.000 abstract 4
- 230000001225 therapeutic effect Effects 0.000 abstract 4
- 230000002209 hydrophobic effect Effects 0.000 abstract 3
- 239000000203 mixture Substances 0.000 abstract 3
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 abstract 2
- 239000006186 oral dosage form Substances 0.000 abstract 2
- 239000007787 solid Substances 0.000 abstract 2
- 230000015556 catabolic process Effects 0.000 abstract 1
- 238000013270 controlled release Methods 0.000 abstract 1
- 238000001816 cooling Methods 0.000 abstract 1
- 238000006731 degradation reaction Methods 0.000 abstract 1
- 229940126534 drug product Drugs 0.000 abstract 1
- 238000013265 extended release Methods 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 230000003301 hydrolyzing effect Effects 0.000 abstract 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
- 238000002844 melting Methods 0.000 abstract 1
- 230000008018 melting Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- ALSCEGDXFJIYES-UHFFFAOYSA-N pyrrolidine-2-carbonitrile Chemical compound N#CC1CCCN1 ALSCEGDXFJIYES-UHFFFAOYSA-N 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Formas de dosis orales solidas incluyen gránulos de fusion de un compuesto terapéutico sensible a la humedad y un componente de fusion hidrofobico. Los gránulos de fusion protegen mejor al compuesto terapéutico de la degradacion hidrolítica. Tales formas de dosis orales solidas también poseen características de liberacion inmedita más que asociadas con productos de fármacos de liberacion extendida o liberacion controlada. Reivindicacion 8: La composicion farmacéutica de acuerdo con la reivindicacion 1, en donde dicho compuesto terapéutico sensible a la humedad es una 2-cianopirrolidina N-(glicilo substituida) o una sal farmacéuticamente aceptable del mismo. Reivindicacion 9: La composicion farmacéutica de acuerdo con la reivindicacion 8, en donde dicha 2-cianopirrolidina N-(glicilo substituida) tiene la formula (1). Reivindicacion 12: Un procedimiento para hacer gránulos que comprende los pasos de: (a) formar una mezcla de un compuesto terapéutico sensible a la humedad con al menos un componente de fusion hidrofobico; (b) calentar dicha mezcla a una temperatura substancialmente cerca del rango de fusion de dicho componente de fusion hidrofobico; (c) granular la mezcla bajo esfuerzo cortante para formar dichos gránulos; y (d) enfriar dichos gránulos a temperatura ambiente.Solid oral dosage forms include fusion granules of a moisture sensitive therapeutic compound and a hydrophobic fusion component. Fusion granules better protect the therapeutic compound from hydrolytic degradation. Such solid oral dosage forms also possess immediate release characteristics rather than associated with extended release or controlled release drug products. Claim 8: The pharmaceutical composition according to claim 1, wherein said moisture sensitive therapeutic compound is a 2-cyanopyrrolidine N- (substituted glycyl) or a pharmaceutically acceptable salt thereof. Claim 9: The pharmaceutical composition according to claim 8, wherein said N-2-cyanopyrrolidine (substituted glycyl) has the formula (1). Claim 12: A process for making granules comprising the steps of: (a) forming a mixture of a moisture sensitive therapeutic compound with at least one hydrophobic fusion component; (b) heating said mixture to a temperature substantially close to the melting range of said hydrophobic fusion component; (c) granulate the mixture under shear to form said granules; and (d) cooling said granules to room temperature.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US60532704P | 2004-08-27 | 2004-08-27 | |
| US61682804P | 2004-10-07 | 2004-10-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR050615A1 true AR050615A1 (en) | 2006-11-08 |
Family
ID=35447883
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP050103558A AR050615A1 (en) | 2004-08-27 | 2005-08-25 | PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20080050443A1 (en) |
| EP (2) | EP1786401B1 (en) |
| JP (1) | JP5147399B2 (en) |
| KR (8) | KR20160017123A (en) |
| CN (1) | CN101010068B (en) |
| AR (1) | AR050615A1 (en) |
| AU (1) | AU2005276583B2 (en) |
| BR (1) | BRPI0514682B8 (en) |
| CA (1) | CA2575499A1 (en) |
| DK (1) | DK1786401T3 (en) |
| ES (1) | ES2647671T3 (en) |
| HU (1) | HUE034653T2 (en) |
| MX (1) | MX2007002253A (en) |
| MY (1) | MY144297A (en) |
| PE (1) | PE20060652A1 (en) |
| PL (1) | PL1786401T3 (en) |
| PT (1) | PT1786401T (en) |
| RU (1) | RU2383332C2 (en) |
| SI (1) | SI1786401T1 (en) |
| TW (1) | TWI402082B (en) |
| WO (1) | WO2006021455A1 (en) |
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR122018014389B1 (en) | 2004-01-20 | 2023-04-25 | Novartis Ag | PROCESS FOR PREPARING PHARMACEUTICAL TABLETS BY DIRECT COMPRESSION |
| RS52163B (en) * | 2004-02-05 | 2012-08-31 | Kyorin Pharmaceutical Co. Ltd. | DERIVATES THE BICYCLESTER |
| AR050615A1 (en) | 2004-08-27 | 2006-11-08 | Novartis Ag | PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION |
| WO2007102286A1 (en) | 2006-03-08 | 2007-09-13 | Kyorin Pharmaceutical Co., Ltd. | Method for producing aminoacetylpyrrolidinecarbonitrile derivative and production intermediate thereof |
| WO2007128801A1 (en) * | 2006-05-08 | 2007-11-15 | Novartis Ag | Combination of organic compounds |
| US8143427B2 (en) | 2007-03-22 | 2012-03-27 | Kyorin Pharmaceutical Co., Ltd. | Method for producing aminoacetylpyrrolidinecarbonitrile derivative |
| DE102008020701A1 (en) * | 2008-04-24 | 2009-10-29 | Bayer Technology Services Gmbh | Formulation with reduced hygroscopicity |
| JP5476305B2 (en) * | 2008-08-07 | 2014-04-23 | 杏林製薬株式会社 | Method for producing bicyclo [2.2.2] octylamine derivative |
| EP2327406A4 (en) * | 2008-08-14 | 2014-04-09 | Kyorin Seiyaku Kk | STABILIZED PHARMACEUTICAL COMPOSITION |
| AR073651A1 (en) * | 2008-09-24 | 2010-11-24 | Novartis Ag | GALENIC FORMULATIONS OF ORGANIC COMPOUNDS |
| WO2010110436A1 (en) | 2009-03-27 | 2010-09-30 | 杏林製薬株式会社 | Matrix-type sustained release preparation containing basic additive |
| JP2011057586A (en) * | 2009-09-08 | 2011-03-24 | Kyorin Pharmaceutical Co Ltd | pH-INDEPENDENT MATRIX TYPE SUSTAINED-RELEASE FORMULATION |
| TR201002256A1 (en) * | 2010-03-24 | 2011-10-21 | Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� | Stable aliskiren formulations |
| US9071358B2 (en) | 2012-06-21 | 2015-06-30 | Qualcomm Incrorporated | Repeater fiber-coax units |
| US8989577B2 (en) | 2012-06-21 | 2015-03-24 | Qualcomm Incorporated | Methods and systems for implementing time-division duplexing in the physical layer |
| US9363017B2 (en) | 2012-07-06 | 2016-06-07 | Qualcomm Incorporated | Methods and systems of specifying coaxial resource allocation across a MAC/PHY interface |
| JP6283316B2 (en) * | 2012-10-26 | 2018-02-21 | 株式会社三和化学研究所 | Anagliptin-containing solid preparation |
| WO2014152207A1 (en) * | 2013-03-15 | 2014-09-25 | Mylan Laboratories, Inc. | Hot melt granulation formulations of poorly water-soluble active agents |
| CN104274408A (en) * | 2013-07-10 | 2015-01-14 | 北京科信必成医药科技发展有限公司 | Fusible coated immediate-release drug microgranule and preparation method thereof |
| US20150366813A1 (en) * | 2014-06-20 | 2015-12-24 | Banner Life Sciences Llc | Liquid-filled immediate release soft gelatin capsules |
| WO2018050892A1 (en) | 2016-09-16 | 2018-03-22 | Galenicum Health S.L. | Vildagliptin pharmaceutical compositions |
Family Cites Families (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL109770A0 (en) * | 1993-05-29 | 1994-11-28 | Smithkline Beecham Corp | Thermal infusion process for preparing controlled release solid dosage forms of medicaments for oral administration and controlled release solid dosage forms of medicaments prepared thereby |
| WO1995005808A1 (en) * | 1993-08-24 | 1995-03-02 | Abbott Laboratories | Oil-based tableting method |
| DE69429710T2 (en) | 1993-11-23 | 2002-08-08 | Euro-Celtique S.A., Luxemburg/Luxembourg | Process for the preparation of a drug composition with delayed drug delivery |
| IL111785A0 (en) | 1993-12-03 | 1995-01-24 | Ferring Bv | Dp-iv inhibitors and pharmaceutical compositions containing them |
| US20020142037A1 (en) | 1996-10-01 | 2002-10-03 | Nabil Farah | Process for the manufacture of a pharmaceutical composition with modified release of active principle comprising a matrix |
| AU4721897A (en) | 1996-10-25 | 1998-05-22 | Tanabe Seiyaku Co., Ltd. | Tetrahydroisoquinoline derivatives |
| US6011155A (en) | 1996-11-07 | 2000-01-04 | Novartis Ag | N-(substituted glycyl)-2-cyanopyrrolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV |
| TW492957B (en) | 1996-11-07 | 2002-07-01 | Novartis Ag | N-substituted 2-cyanopyrrolidnes |
| ATE286721T1 (en) * | 1997-09-19 | 2005-01-15 | Shire Lab Inc | SOLID SOLUTION BEADS |
| DE19823831A1 (en) | 1998-05-28 | 1999-12-02 | Probiodrug Ges Fuer Arzneim | New pharmaceutical use of isoleucyl thiazolidide and its salts |
| CO5150173A1 (en) | 1998-12-10 | 2002-04-29 | Novartis Ag | COMPOUNDS N- (REPLACED GLYCLE) -2-DIPEPTIDYL-IV PEPTIDASE INHIBITING CYANOPIRROLIDINS (DPP-IV) WHICH ARE EFFECTIVE IN THE TREATMENT OF CONDITIONS MEDIATED BY DPP-IV INHIBITION |
| US6107317A (en) | 1999-06-24 | 2000-08-22 | Novartis Ag | N-(substituted glycyl)-thiazolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV |
| US20020015730A1 (en) * | 2000-03-09 | 2002-02-07 | Torsten Hoffmann | Pharmaceutical formulations and method for making |
| IL157179A0 (en) | 2001-02-02 | 2004-02-08 | Takeda Chemical Industries Ltd | Fused heterocyclic compounds |
| UA74912C2 (en) | 2001-07-06 | 2006-02-15 | Merck & Co Inc | Beta-aminotetrahydroimidazo-(1,2-a)-pyrazines and tetratriazolo-(4,3-a)-pyrazines as inhibitors of dipeptylpeptidase for the treatment or prevention of diabetes |
| US7985422B2 (en) * | 2002-08-05 | 2011-07-26 | Torrent Pharmaceuticals Limited | Dosage form |
| EP1537880A4 (en) * | 2002-09-11 | 2009-07-01 | Takeda Pharmaceutical | PREPARATION FOR PROLONGED RELEASE |
| AU2003298596B2 (en) | 2002-10-18 | 2008-12-18 | Merck Sharp & Dohme Corp. | Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes |
| DE60332856D1 (en) | 2002-10-23 | 2010-07-15 | Bristol Myers Squibb Co | GLYCINNITRIL BASED DIPEPTIDYLPEPTIDASE IV INHIBITORS |
| AR050615A1 (en) | 2004-08-27 | 2006-11-08 | Novartis Ag | PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION |
-
2005
- 2005-08-25 AR ARP050103558A patent/AR050615A1/en not_active Application Discontinuation
- 2005-08-25 PE PE2005000979A patent/PE20060652A1/en not_active Application Discontinuation
- 2005-08-26 JP JP2007528755A patent/JP5147399B2/en not_active Expired - Lifetime
- 2005-08-26 WO PCT/EP2005/009252 patent/WO2006021455A1/en not_active Ceased
- 2005-08-26 EP EP05775067.1A patent/EP1786401B1/en not_active Expired - Lifetime
- 2005-08-26 DK DK05775067.1T patent/DK1786401T3/en active
- 2005-08-26 TW TW094129377A patent/TWI402082B/en not_active IP Right Cessation
- 2005-08-26 KR KR1020167002363A patent/KR20160017123A/en not_active Withdrawn
- 2005-08-26 RU RU2007110953/15A patent/RU2383332C2/en active
- 2005-08-26 KR KR1020177024422A patent/KR20170103039A/en not_active Ceased
- 2005-08-26 KR KR1020167032323A patent/KR20160136465A/en not_active Withdrawn
- 2005-08-26 KR KR1020227013566A patent/KR20220061249A/en not_active Withdrawn
- 2005-08-26 PL PL05775067T patent/PL1786401T3/en unknown
- 2005-08-26 SI SI200532179T patent/SI1786401T1/en unknown
- 2005-08-26 MX MX2007002253A patent/MX2007002253A/en active IP Right Grant
- 2005-08-26 KR KR1020207019819A patent/KR20200087870A/en not_active Ceased
- 2005-08-26 EP EP16169370.0A patent/EP3087975A1/en not_active Ceased
- 2005-08-26 KR KR1020077004461A patent/KR20070049646A/en not_active Ceased
- 2005-08-26 KR KR1020137009959A patent/KR101613775B1/en not_active Expired - Fee Related
- 2005-08-26 PT PT57750671T patent/PT1786401T/en unknown
- 2005-08-26 CA CA002575499A patent/CA2575499A1/en not_active Abandoned
- 2005-08-26 KR KR1020197001094A patent/KR20190006612A/en not_active Ceased
- 2005-08-26 BR BRPI0514682A patent/BRPI0514682B8/en active IP Right Grant
- 2005-08-26 HU HUE05775067A patent/HUE034653T2/en unknown
- 2005-08-26 ES ES05775067.1T patent/ES2647671T3/en not_active Expired - Lifetime
- 2005-08-26 US US11/573,658 patent/US20080050443A1/en not_active Abandoned
- 2005-08-26 CN CN2005800289311A patent/CN101010068B/en not_active Expired - Fee Related
- 2005-08-26 MY MYPI20054015A patent/MY144297A/en unknown
- 2005-08-26 AU AU2005276583A patent/AU2005276583B2/en not_active Ceased
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FC | Refusal |